Clearance Summary
DC-UIBC-CO2-CAL, MODEL SE-153 received FDA 510(k) clearance under submission number K013178, sponsored by Diagnostic Chemicals , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2001-12-18.
- Submission: K013178
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1150
- Decision date: 2001-12-18
Classification & Regulation
This clearance is catalogued under FDA product code JIX and 21 CFR 862.1150, within the Clinical Chemistry review panel as a Class II device.